WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INFINITY TALAR COMPONENT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 08/31/2023 |
Event Type
Injury
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial and talar components due to pain, swelling and subjective instability.
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial and talar components due to pain, swelling and subjective instability.
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Manufacturer Narrative
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Correction - h6 (device code, results code and conclusion code).The reported event could be confirmed, based on available medical record and health care professionals.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component loosed and migrated due to cyst formation.Talar component has some radiolucencies around it.Based on investigation, the root cause was attributed to a patient related issue.The failure caused due to loosening of tibial and radiolucencies around talar component.If the device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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